IPC Flags ADR Risks with Polymyxin B, Clomipramine, Famotidine
New Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest drug safety alert for March 2026, has reported safety signals indicating that the antibiotic Polymyxin B may be associated with adverse drug reactions (ADRs) such as hypokalemia, while the antidepressant Clomipramine may be associated with akathisia, and the antiulcer agent Famotidine may be associated with fixed drug eruption.
In connection with the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering polymyxin B, clomipramine, and famotidine.
This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Polymyxin B is an antibiotic primarily used for the treatment of severe infections caused by susceptible Gram-negative organisms. It is indicated in urinary tract infections caused by Pseudomonas aeruginosa and Escherichia coli, bloodstream infections caused by P. aeruginosa, Enterobacter aerogenes, and Klebsiella pneumoniae, as well as meningeal infections caused by P. aeruginosa.
Following analysis of PvPI data, polymyxin B has been reported to be associated with hypokalemia, a condition characterized by low potassium levels in the blood, which may lead to muscle weakness, cramps, and cardiac disturbances.
Clomipramine is a tricyclic antidepressant indicated for the treatment of obsessive-compulsive disorder (OCD), phobic states, and depression, particularly when sedation is required. The PvPI analysis suggests that clomipramine may cause akathisia, a neuropsychiatric condition marked by a feeling of inner restlessness and an inability to stay still.
Famotidine is a histamine H2 receptor antagonist used in the treatment of duodenal and peptic ulcers and Zollinger–Ellison syndrome. According to the safety alert, famotidine may be associated with fixed drug eruption, a type of skin reaction that recurs at the same site upon re-exposure to the drug and is characterized by well-defined reddish or dark patches.
Now, as per the issued drug safety alert, the following suspected drugs are associated with the ADRs, as given below:
| S. No. | Suspected Drug | Indication(s) | Adverse Drug Reactions (ADRs) |
|---|---|---|---|
| 1 | Polymyxin B | Urinary tract infections caused by P. aeruginosa and E. coli, bloodstream infections caused by P. aeruginosa, E. aerogenes and K. pneumoniae, meningeal infections caused by P. aeruginosa | Hypokalemia |
| 2 | Clomipramine | Antidepressant – Obsessive Compulsive Disorders, phobic states and depression (when sedation is required) | Akathisia |
| 3 | Famotidine | Indicated in the treatment of duodenal & peptic ulcer, Zollinger–Ellison syndrome | Fixed Drug Eruption |
In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, has advised healthcare professionals, patients, and consumers to closely monitor the possibility of the above ADRs associated with the use of the above suspected drugs.
Further, the safety alert added, "If, such reactions are encountered, please report to the NCC-PvPI, IPC by filling of the Suspected Adverse Drug Reactions Reporting Form by HCPs, Medicines Side Effect Reporting Form by Consumer (download from https://www.ipc.gov.in) or through the PvPI Helpline No. 1800-180-3024".
To view the official notice, click the link below:
